IDCRC Newsletter: July 2022

IDCRC Profile:

Flor M. Munoz, MD, MSc

Associate Professor of Pediatrics, Molecular Virology and Microbiology at Baylor College of Medicine and Medical Director, Transplant Infectious Diseases at Texas Children's Hospital

“Dr. Munoz credits the collaborative nature of the IDCRC network as a strength of the consortium and example of the importance of IDCRC in the future.”

READ MORE
 

News

Mentoring and Training Key Function Committee Chair to Step Down

The IDCRC thanks Kathy Edwards, MD, Sarah H. Sell and Cornelius Vanderbilt Chair in Pediatrics at Vanderbilt University, as she steps down as the inaugural co-chair of the IDCRC Mentoring and Training Key Function Committee and for years of service supporting the IDCRC and our mentees. She was pivotal in standing up the Mentoring and Training Key Function Committee and is a great mentor by every standard. 

READ MORE
 

Lara A. Danziger-Isakov, MD, MPH to co-chair Mentoring and Training Key Function Committee

Dr. Danziger-Isakov is a professor in the Department of Pediatrics at the University of Cincinnati and the director of the Immunocompromised Host Infectious Disease Service at Cincinnati Children’s. She has served as a member of the Mentoring & Training Key Function Committee (KFC) since its inception. She specializes in treating infections for a variety of patient populations, including those who have received solid organ transplants and hematopoietic stem cell transplants, immunocompromised patients and patients undergoing treatment for various cancers. 

READ MORE
 

IDCRC study finds rapid decline in vaccine-boosted neutralizing antibodies against Omicron variant BA.5

Although COVID-19 booster vaccinations in adults elicit high levels of neutralizing antibodies against the Omicron variant of SARS-CoV-2, antibody levels decrease substantially within three months, according to new clinical trial data. The findings, published today in Cell Reports Medicine, are from an ongoing study led by the Infectious Diseases Clinical Research Consortium (IDCRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. NIAID is sponsoring the trial.

READ MORE
 

Statement from NIH and BARDA on the Novavax COVID-19 Vaccine

The Centers for Disease Control and Prevention (CDC) has recommended that Novavax’s COVID-19 vaccine be used as another primary series option for adults in the United States ages 18 years and older. The Food and Drug Administration (FDA) previously authorized for emergency use the protein-based vaccine, known as NVX-CoV2373.

Several VTEU’s participated in the pivotal trial, with Dr. Karen Kotloff, University of Maryland Center for Vaccine Development PI, served as the national co-lead for the study.

READ FULL RELEASE
 

U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Individuals Aged 18 and Over

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and over.

READ MORE
 

Research Ride Podcast Episode 1 with Nadine Rouphael, MD

In this episode, Dr. Rouphael discusses her journey with Emory's VTEU and its involvement in the development of the COVID-19 vaccines, the future of the COVID-19 vaccines, as well as her family and her love of cooking.

 

Young children and COVID-19 vaccines

The Pfizer BioNTech vaccine has been approved for children six months through four years, and the Moderna vaccine for ages six months through five years. Evan Anderson, MD, professor of pediatrics and medicine, and an infectious disease physician at Emory and Children’s Healthcare of Atlanta. Anderson was involved in the clinical trials testing vaccines for children six months to 11 years of age at Emory and Children’s. 

Click below to read the interview with Anderson who answers questions about the new vaccine approval for children five and under.

READ FULL INTERVIEW
 

Publications

NOTE: Please include the following citation in any publications resulting from direct or indirect IDCRC support: 

"Supported by the Infectious Diseases Clinical Research Consortium through the National Institute for Allergy and Infectious Diseases of the National Institutes of Health, under award number UM1AI148684. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."

 

View recent publications below:

  • Rapid Decline in Vaccine-Boosted Neutralizing Antibodies Against SARS-CoV-2 Omicron Variant

  • SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses

  • Effect of Subcutaneous Casirivimab and Imdevimab Antibody Combination vs Placebo on Development of Symptomatic COVID-19 in Early Asymptomatic SARS-CoV-2 Infection

  • Booster of mRNA-1273 Strengthens SARS-CoV-2 Omicron Neutralization

     

 
 

Training

Mentee Profile:

Jared Frisby, DO, Infectious Diseases Fellow, Saint Louis University

Dr. Frisby's research focuses on improving inpatient and outpatient vaccine utilization, improving medical education and antimicrobial stewardship.

IDCRC TRAINING
 

Job Postings

  • Joint ID/EIS Fellowship

  • Post-doctoral Fellow - HIV Cure- Chahroudi Lab

  • Postdoctoral Fellow - HIV/SIV persistence and cure – Chahroudi Lab

  • Senior Medical Science Liaison – Immunology

  • Southern Research Available Positions in Birmingham, AL

Visit the IDSA Career Center to browse over 200 ID/HIV Medicine job postings.

 

Funding Opportunities

NIH Funding Opportunities Specific to COVID-19
This page contains a listing of active and expired funding opportunities.

Understanding the Clinical History of Bacterial Sexually Transmitted Infections (STI) to Accelerate Diagnostic and Vaccine Development (R01 Clinical Trial Not Allowed) - LOI Due August 12
The purpose of this FOA is to support studies on the clinical history of three STIs: syphilis, gonorrhea and chlamydia. Improved understanding of the human immune response after infection through diagnosis and treatment will provide a much-needed knowledge base to accelerate vaccine and diagnostic development.

Partnerships for Development of Vaccines Against Select Enteric Pathogens (R01 Clinical Trial Not Allowed) – LOI Due August 14
The purpose of this FOA is to solicit research applications focused on advancing development of vaccine candidates against Enterotoxigenic Escherichia coli (ETEC), Salmonella enterica serotype Paratyphi A and two Shigella species, Shigella flexneri and Shigella sonnei.

Enhancing HIV Reservoir Susceptibility to Elimination (R01 Clinical Trial Not Allowed) – Due August 30
The purpose of this FOA is to support basic research to define cellular and molecular mechanisms within persistent HIV reservoir cells that promote survival and resistance to virus-induced and immune-mediated cell death, and to identify novel therapeutic targets that could sensitize HIV-infected cells to eradication strategies.

NIH Director’s Transformative Research Award (R01 - Clinical Trial Optional) – Due September 1
The NIH Common Fund announces the FY2023 funding opportunity for the NIH Director’s Transformative Research Award in the High-Risk, High-Reward Research program. The Transformative Research Award supports individuals or teams proposing unusually innovative research projects that are inherently risky and untested but have the potential to create or overturn fundamental paradigms.

Healthcare Infection Society: Major Research Grant - Due September 1
The purpose of this FOA is to support work on the subject of healthcare-associated infections and infection prevention and control.          

Notice of Special Interest (NOSI): Towards Developing a Cure for HBV in HIV/HBV Co-Infection – Due September 5
The purpose of this NOSI is to encourage applications for support of innovative basic, translational, and clinical research to identify and address the unique challenges to achieving HBV cure in the presence of HIV. 

A Multi-omics Approach to Immune Responses in HIV Vaccination and Intervention (P01 Clinical Trial Not Allowed) – LOI Due September 13
The purpose of this FOA is to support multi-disciplinary, multi-component applications proposing the use of omics technologies to advance preventative and/or therapeutic vaccinations, and/or immunomodulatory cure interventions for HIV. Projects will integrate omics, computational and hypothesis-driven experimental approaches to interrogate immune responses to HIV vaccination and/or cure strategies.

 

IDCRC Studies

Active Studies
Recruiting Volunteers

  • Gritstone Second Generation COVID-19 Vaccine, CORAL Program
     

  • Moderna’s mRNA-1273 vaccine, the KidCOVE Study
  • Heterologous Prime Boost, Mix and Match Study
     
  • Mucosal immunity against GC after 4CMenB Vaccination
     
  • Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine
     
  • COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)
     
  • Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults

Fully Enrolled Studies
in Follow-up

  • Moderna’s mRNA-1273 vaccine, The COVE Study™
     

  • Moderna’s mRNA-1273.351 Variant vaccine
     

  • AstraZeneca Study of AZD1222
     

  • The ENSEMBLE Study with Janssen’s Ad26.COV2.S Investigational Vaccine
     

  • Novavax Study of NVX-CoV2373
     

  • Regeneron’s 10933 and 10987 Monoclonal Antibodies, the REGN-COV2 Study
     

  • Eli Lilly’s LY3819253 Antibody, the BLAZE-2 Study
     
  • SARS-CoV-2/COVID-19 PREVALENCE STUDY, The COMPASS Study
     
  • SARS-CoV-2 Vaccines in Pregnancy and Postpartum, the MOMI-VAX Study
IDCRC ACTIVE AND COMPLETED STUDIES
 

IDCRC Concept Quick Stats

ICP Status

  • Approved: 36

  • Administratively Not Supported: 19

  • Revise and Resubmit: 7

  • Withdrawn: 8

  • Liaisons: 3

  • EWGs: 2

  • Not Approved: 36

  • EMT: 2

  • Other: 8

EWG Assignment

  • COVID: 84

  • Respiratory: 13

  • Sexually Transmitted Infections: 8

  • Malaria and Tropical Dis.: 5

  • Enteric Inf.: 4

  • Emerging Infections: 8

ECP Status

  • Protocol Development: 7

  •  IDCRC concept study underway: 4

  • Moved forward through other processes: 4

  • Pending: 8

  • Not approved: 2

  • In process: 6

  • On hold: 7

  • Withdrawn: 3

NOTE:

  • Protocols Transitioned to IDCRC for Protocol Implementation: 5
  • Status: Protocol Dev/Pre-implementation: 4; Active Study: 1
  • Other studies in process (not from an IDCRC concept): 4
  • Note: One concept was referred to both STI and Emerging Infections EWGs

IDCRC STUDIES
 

Communication Resources

COMMUNICATION TOOLKIT
 

Please submit IDCRC news to epthomp@emory.edu for inclusion in the monthly newsletter and IDCRC.org.

VISIT IDCRC WEBSITE
NEWSLETTER ARCHIVE
SUBSCRIBE TO NEWSLETTER
Twitter
 
Woodruff Health Sciences Center
Emory University
1440 Clifton Road NE
Atlanta, GA 30322, United States

Subscribe

Preferences  |  Unsubscribe